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NY N005717

January 26, 2007



TARIFF NO.: 3004.90.9190

Mr. Mark DeFries
Solace Nutrition
46 Kilvert Street
Warwick, RI 02866

RE: The tariff classification of PreKUnil® LNAA Tablets® from Denmark

Dear Mr. DeFries:

In your letter dated January 18, 2007, you requested a tariff classification ruling.

The subject product, PreKUnil® LNAA Tablets®, is described as a “medical food,” for use under medical supervision, for the dietary management of Phenylketonuria (PKU)

“Phenylketonuria (PKU) is an inborn error of metabolism in which the normal conversion of (the amino acid) phenylalanine to (the amino acid) tyrosine in the body does not occur and there is a buildup of phenylalanine concentration in the blood. This metabolic disorder causes mental retardation. If this genetic disorder is discovered soon after birth, it is possible to place the infant on a diet very low in phenylalanine-containing proteins and thus minimize the phenylalanine buildup in the body, averting the serious mental retardation that ordinarily is seen in the untreated PKU patient.” Remington: The Science and Practice of Pharmacy, 21st Edition (p. 589). . The tablets contain large neutral amino acids (LNAAs) as the active ingredient. Wording on the printed label found on the container in which the tablets are supplied states that the tablets are “[N]ot for the general population of consumers.”

Pursuant to HQ 083000, dated September 19, 1990, the applicable subheading for PreKUnil® LNAA Tablets® will be 3004.90.9190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Other.” The rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.


Robert B. Swierupski

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